NCT01422564终止4 期
A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 41
- 主要终点
- Revision Rate
研究概览
简要总结
This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female subjects 65 years of age or older
- •Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
- •Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
- •Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.
排除标准
- •Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
- •Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
- •Subjects with active infections.
- •Subjects with malignancy in the area of the involved hip joint.
- •Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •Subjects with a diagnosis of Fibromyalgia
- •Female subjects who are pregnant or may be pregnant.
- •Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
- •Subjects who have a known sensitivity to device materials.
结局指标
主要结局
Revision Rate
时间窗: 4 years
次要结局
- Wear and osteolysis(5-15 years)
- Harris Hip Score(immediate post-op, 6 months, 1 year, 2 years, 4 years)
- Dislocation Rate(4 years)
- Metal Ions(4 years)
- Complication Rate(4 years)
- Gait Analysis(6 months and 1 year post-op)
研究者
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